Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to collect long-term safety and tolerability data for aficamten.

Official Title

A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

Keywords

Symptomatic Hypertrophic Cardiomyopathy (HCM), Obstructive Hypertrophic Cardiomyopathy, oHCM, CK-3773274, CK-274, Non obstructive hypertrophic cardiomyopathy, nHCM, HCM, Hypertrophic cardiomyopathy, Aficamten, REDWOOD-OLE, CY 6022, FOREST-HCM, Forest, Cardiomyopathies, Hypertrophy, Aficamten (5 - 20 mg), Aficamten up to 20 mg

Eligibility

You can join if…

Open to people ages 18-85

  • Completion of a Cytokinetics trial investigating aficamten
  • LVEF ≥ 55% at the Screening Visit

You CAN'T join if...

  • Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
  • Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
  • Since completion of a previous trial of aficamten has:
    • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) < 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) < 100 bpm and/or rhythm is stable > 30 days
    • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
  • Had a confirmed LVEF < 40% with an associated dose interruption during participation in a prior study with aficamten
  • History of implantable ICD placement within 30 days prior to screening.

Locations

  • UCSF Medical Center
    San Francisco California 94143 United States
  • Cedar-Sinai Medical Center
    Los Angeles California 90048 United States
  • Cedars-Sinai Medical Center (Smidt Heart Institute)
    Los Angeles California 90048 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Cytokinetics
ID
NCT04848506
Phase
Phase 2/3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated